US healthcare company Johnson & Johnson (NYSE: JNJ) on Monday announced new 96-week data from the Phase 3 GRAVITI, GALAXI 2, and GALAXI 3 studies, confirming the long-term efficacy and safety of TREMFYA (guselkumab) in adults with moderately to severely active Crohn's disease.

The results, presented at the 2025 American College of Gastroenterology Annual Scientific Meeting, showed sustained clinical and endoscopic remission over two years.

The company says that TREMFYA is the first and only approved dual-acting monoclonal antibody that blocks interleukin-23 (IL-23) and binds to CD64, targeting cells that produce IL-23. It is also the only IL-23 inhibitor to demonstrate durable remission using a fully subcutaneous regimen.

At Week 96, over 85% of patients in both the GRAVITI and GALAXI studies achieved clinical remission, with endoscopic response rates reaching around 70% and deep remission observed in approximately half of participants. Safety outcomes remained consistent with TREMFYA's established profile.

Johnson & Johnson highlighted that TREMFYA is approved in the US for both intravenous and subcutaneous induction in Crohn's disease and ulcerative colitis, offering patients flexible treatment options. The company said the findings reinforce its commitment to advancing therapies for inflammatory bowel diseases.